Quantafluor Fluorescent Test Reagents
FDA 510(k) K813592 · Kallestad Laboratories, Inc.
510(k) numberK813592
Submission
- Device name
- Quantafluor Fluorescent Test Reagents
- Applicant
- Kallestad Laboratories, Inc.
Mchenry, IL, US - Received
- December 28, 1981
- Decision date
- January 18, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DHN – Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5100
- Specialty
- Immunology
Other 510(k)s with product code DHN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K201956 | Zeus IFA ANA HEp-2 Test System, Zeus dIFineDHN · Traditional | Zeus Scientific, Inc. | 04/29/2022SE |
| K172745 | ImmuGlo HEp-2 Elite IFADHN · Traditional | Immco Diagnostics, Inc. | 06/05/2018SE |
| K153117 | AESKUSLIDES ANA HEp-2-Gamma, HELIOS FULLY AUTOMATED IFA SYSTEMDHN · Traditional | Aesku Systems GmbH&Co.Kg | 07/28/2016SE |
| K160265 | Image Navigator by Immuno ConceptsDHN · Traditional | Immuno Concepts, N.A. , Ltd. | 06/17/2016SE |
| K141827 | Euroimmun Ifa 40: HEP-20-10; Europattern Microscope and SoftwareDHN · Traditional | Euroimmun Us, Inc. | 04/17/2015SE |
| K150155 | NOVA Lite DAPI ANA KitDHN · Traditional | Inova Diagnostics, Inc. | 04/08/2015SE |
| K131791 | Ifa 40: HEP-20-10DHN · Traditional | Euroimmun US | 02/26/2014SE |
| K120889 | Aeskuslides Ana HEP-2DHN · Traditional | Aesku Diagnostics | 10/15/2012SE |
| K070763 | Euroimmun Ana Ifa: HEP-20-10DHN · Traditional | Euroimmun Us, LLC | 05/22/2007SE |
| K042680 | Rhigene Hep-Ana Test SystemDHN · Traditional | Corgenix, Inc. | 11/19/2004SE |
More from Corgenix, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K863681 | Pathfinder(Tm) Direct Antigen Detection SystemLJP · Traditional | 12/03/1986SE |
| K862917 | Pathfinder Rotavirus ChemiluminescentLIQ · Traditional | 10/22/1986SE |
| K863682 | Pathfinder(Tm) Specimen Collection KitJSM · Traditional | 10/10/1986SE |
| K862743 | Pathfinder(Tm) Respiratory Syncytial VirusGQG · Traditional | 09/29/1986SE |
| K862313 | Kallestad Sm/Rnp Test ReagentLKJ · Traditional | 08/06/1986SE |
| K862710 | Kallestad Ssa/Ssb Ena Test ReagentsLLL · Traditional | 07/29/1986SE |
| K855014 | Quantimetric Plus Calibrator/Control Set aJIX · Traditional | 03/14/1986SE |
| K855010 | Quantimetric Plus Igm Reagent KitDFT · Traditional | 02/28/1986SE |
| K855013 | Quantimetric Plus Support PackDEH · Traditional | 02/26/1986SE |
| K855012 | Quantimetric Plus C4 Reagent KitDBI · Traditional | 02/26/1986SE |
Questions and answers
When was Quantafluor Fluorescent Test Reagents cleared by the FDA?
Quantafluor Fluorescent Test Reagents (K813592) received a 510(k) decision of Substantially Equivalent on January 18, 1982, 21 days after the submission was received.
What is the product code of K813592?
The FDA product code is DHN – Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5100.